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The Geratherm UniqueResc
+
can be identified as
follows:
Manufacturer’s designation:
Model:
Geratherm UniqueResc
+
Rescue Warming System
Type:
R130
R150
Device/ software version:
Version: 1. and 2. digit of the serial number
Serial number:
The serial number is to be found under the transparent
window of the control cover plate, on the commercial
invoice and in the attached documentation.
MPG classification:
Geratherm UniqueResc
+
has been categorised as a
Class IIb device.
Geratherm UniqueResc
+
meets the requirements of
Council Directive 93/42 EEC of 14.06.93 on Medical
Devices and of the standard DIN EN 60601-1 (Medi-
cal electrical equipment, Part 1: General requirements
for safety), DIN EN 60601-1-2 (Medical electrical
equipment Part 1-2: General requirements for safety
– Collateral standard: Electromagnetic compatibility
– Requirements and Tests), and DIN EN 60601-2-35
(Medical electrical equipment, Part 2: Particular re-
quirements for the safety of blankets, pads and mat-
tresses intended for the warming of patients in medical
use).
A DIN EN ISO 13485 certified quality management sy-
stem ensures that these requirements are met and en-
titles the manufacturer to use the CE 0118 label.
1 Identification
